Class II · Moderate risk Ongoing
Nystatin Cream USP
Reason Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Nystatin Topical Powder
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: potential presence of plastic particles.
What was recalled
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- NDC code
- 42543-052-61
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1059-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nystatin recalls
See all
Class II · Moderate risk Ongoing
Nystatin 150 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 2 Bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.